SAVELLA- milnacipran hydrochloride tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MILNACIPRAN HYDROCHLORIDE (UNII: RNZ43O5WW5) (MILNACIPRAN - UNII:G56VK1HF36)

Mevcut itibaren:

Unit Dose Services

INN (International Adı):

MILNACIPRAN HYDROCHLORIDE

Kompozisyon:

MILNACIPRAN HYDROCHLORIDE 25 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)] . The use of MAOIs intended to treat psychiatric disorders with Savella or within 5 days of stopping treatment with Savella is contraindicated because of an increased risk of serotonin syndrome. The use of Savella within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.5), Warnings and Precautions (5.2)] . Starting Savella in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.6), Warnings and Precautions (5.2)] . Pregnancy Category C Risk Summary There are no adequate or well-controlled studies in pregnant women. Neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine (such as Savella), or selective serotonin reuptake i

Ürün özeti:

Product: 50436-9993 NDC: 50436-9993-2 60 TABLET, FILM COATED in a BOTTLE

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

SAVELLA- MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
Unit Dose Services
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FDA-Approved Medication Guide
MEDICATION GUIDE
Savella® (Sa-vel-la)
(milnacipran HCl)
Tablets
Savella is not used to treat depression, but it acts like medicines
that are used to treat depression
(antidepressants) and other psychiatric disorders.
Read the Medication Guide that comes with Savella® before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
healthcare provider about your medical condition or treatment. Talk
with your healthcare provider if there
is something you do not understand or want to learn more about.
What is the most important information I should know about Savella?
Savella and antidepressant medicines may cause serious side effects,
including:
1.
Suicidal thoughts or actions:
•
Savella and antidepressant medicines may increase suicidal thoughts or
actions in some
children, teenagers, and young adults within the first few months of
treatment or when the
dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts or actions. Watch for these changes and call your healthcare
provider right away
if you notice:
•
New or sudden changes, in mood, behavior, thoughts, or feelings,
especially if
severe.
•
Pay particular attention to such changes when Savella is started or
when the dose is
changed.
•
Keep all follow-up visits with your healthcare provider and call
between visits if
you are worried about symptoms.
Call your healthcare provider right away or go to the nearest hospital
emergency room if
you have any of the following symptoms, especially if they are new,
worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive, being angry, or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trou

Ürün özellikleri

SAVELLA- MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAVELLA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SAVELLA.
SAVELLA® (MILNACIPRAN HCL) TABLETS
INITIAL U.S. APPROVAL: 2009
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
INCREASED RISK OF SUICIDAL IDEATION, THINKING, AND BEHAVIOR IN
CHILDREN, ADOLESCENTS, AND YOUNG ADULTS
TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS (5.1).
SAVELLA IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (1, 8.4).
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS - Serotonin Syndrome (5.2)
10/2016
INDICATIONS AND USAGE
Save lla
is a selective serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the management of
fibromyalgia (1).
Savella is not approved for use in pediatric patients (1).
DOSAGE AND ADMINISTRATION
Administer Savella in two divided doses per day (2.1).
Based on efficacy and tolerability, dosing may be titrated according
to the following schedule (2.1):
Recommended dose is 100 mg/day (2.1).
May be increased to 200 mg/day based on individual patient response
(2.1).
Dose should be adjusted in patients with severe renal impairment
(2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with Savella or within 5
days of stopping treatment with Savella. Do not use Savella within 14
days of stopping an MAOI intended to treat
psychiatric disorders. In addition, do not start Savella in a patient
who is being treated with linezolid or intravenous
methylene blue (4.1, 5.2).
WARNINGS AND PRECAUTIONS
Suicidality: Monitor for worsening of depressive symptoms and suicide
risk (5.1).
Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs
and SNRIs, including Savella, both when
taken alon